—#188991

Product

Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK

FDA product code: MMI — Immunoassay Method, Troponin Subunit
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K172783, K172787
Affected lot / code info: Catalog Number:B52699 Lot Number / UDI Code: 921491 / (01)15099590693183(17)201130(11)191201(10)921491; 921638 / (01)15099590693183(17)201231(11)200101(10)921638; 921631 / (01)15099590693183(17)210131(11)200201(10)921631; 921750 / (01)15099590693183(17)210131(11)200201(10)921750; 921805 / (01)15099590693183(17)210228(11)200229(10)921805; 921831 / (01)15099590693183(17)210331(11)200331(10)921831; 921943 / (01)15099590693183(17)210430(11)200430(10)921943; 922000 / (01)15099590693183(17)210531(11)200531(10)922000; 922039 / (01)15099590693183(17)210630(11)200630(10)922039; 922040 / (01)15099590693183(17)210731(11)200731(10)922040; 922062 / (01)15099590693183(17)210731(11)200731(10)922062; 922145 / (01)15099590693183(17)210831(11)200831(10)922145; 922146 / (01)15099590693183(17)210930(11)200930(10)922146; 922338 / (01)15099590693183(17)210930(11)200930(10)922338; 922440 / (01)15099590693183(17)211031(11)201031(10)922440; 922545 / (01)15099590693183(17)211031(11)201031(10)922545; 922547 / (01)15099590693183(17)211130(11)201130(10)922547; 922713 / (01)15099590693183(17)211231(11)201231(10)922713; 922714 / (01)15099590693183(17)211231(11)201231(10)922714; 922722 / (01)15099590693183(17)220131(11)210131(10)922722; 922897 / (01)15099590693183(17)220131(11)210131(10)922897; 124235 / (01)15099590693183(17)220228(11)210228(10)124235; 124339 / (01)15099590693183(17)220228(11)210228(10)124339; 922898 / (01)15099590693183(17)220228(11)210228(10)922898; 124340 / (01)15099590693183(17)220331(11)210331(10)124340; 124348 / (01)15099590693183(17)220430(11)210430(10)124348; 124353 / (01)15099590693183(17)220430(11)210430(10)124353; 124688 / (01)15099590693183(17)220430(11)210430(10)124688; 124354 / (01)15099590693183(17)220531(11)210531(10)124354; 124355 / (01)15099590693183(17)220630(11)210630(10)124355; 124356 / (01)15099590693183(17)220630(11)210630(10)124356; 124357 / (01)15099590693183(17)220630(11)210630(10)124357;

Why it was recalled

Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may cause carryover into the hsTnl reagent pack. The carryover is caused by sample-to-pack carryover predominantly into the particle well of the reagent pack by way of the probe. The particle well then becomes contaminated by the high sample from the probe. The extent of the carryover is dependent on sample concentration and frequency of high concentration samples.

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

During the week of 08/09/2021, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification Letter via mail or email informing customer of possible carryover with in-use, open (punctured) hsTnI reagent packs, and the impact of carryover on patient samples that are tested from the same reagent pack as a sample with a high cardiac troponin (cTnI) concentration >270,000 pg/mL (ng/L), or the carryover may also impact a different reagent pack. Clinical carryover can affect the results of all subsequent samples that are tested from the affected pack. Customer are instructed to: - If an hsTnI result >270,000 pg/mL (ng/L) are observed, perform the following steps: 1. Remove and discard all open Access hsTnI reagent packs. For customers in the United States, if replacement products are needed, complete the attached Replacement Order Form and email to askbeckman@beckman.com or fax to (866) 294-7850 OR Call Client Services at (800) 526-3821. 2. Load a single Access hsTnI reagent pack. 3. Run the current low level hsTnI QC on all reagent pipettors configured for hsTnI to verify that there is no further carryover. NOTE: UniCel DxI operators can test all configured reagent pipettors by setting up a QC file as outlined in Appendix A (included with the recall notice). 4. If the QC result is within the laboratory s defined ranges for each pipettor configured, repeat each positive hsTnI sample that was tested after the >270,000 pg/mL (ng/L) cTnI sample and then continue normal operation. Load additional reagent packs if it is appropriate for the laboratory s testing requirements. 5. If the QC result are not within the acceptable range, contact the Recalling Firm's Customer Technical Support for further assistance. Additional instructions: - Download the most current version of the hsTnI reagent -nstructions for Use (IFU) from the Recalling Firm's website. Update laboratory procedures as appropriate. -Share this information with laboratory staff and retain this not

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: U.S.: AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, ME, MD, MI, MN, MS, MO, NC, ND, NE, NV, NJ, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, VA, WA, WI, WV, and WY O.U.S.: Algeria, Andorra, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Canada, China, Croatia, Cura¿ao, Czech Republic, Denmark, Egypt, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Niger, Nigeria, Norway, Oman, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Swaziland, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vietnam, Yemen, and Zimbabwe

Timeline

Recall initiated: 2021-08-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188991. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.