—#152588

Product

N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usage: In-vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry with BN II and BN ProSpec System. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

FDA product code: LPS — Urinary Homocystine (Nonquantitative) Test System
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K052788
Affected lot / code info: Lot 802907632, Exp. 2017-02-13

Why it was recalled

The firm confirmed a reduced once-opened and on-board stability for N Latex Homocysteine (HCY) OPAX03 lot 802907632 that may result in erroneously reduced or elevated homocysteine values. The stability issue may lead to higher than expected lot-to-lot variation and an impaired product performance.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

URGENT MEDICAL DEVICE RECALL Letter (PP17-005.A.US, dated 1/11/2016) was sent to the sole US consignee via FedEx on 1/11/2017 to notify the customer of the issue. All N Latex HCY OPAX03 lot 802907632 customers are being instructed to discard N Latex HCY OPAX03 lot 802907632. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the UMDR within 30 days. On 1/13/2017, an URGENT MEDICAL DEVICE RECALL letter (PP17-005.B.US, dated 1/13/2017) was sent to the sole US consignee with instructions to discontinue use of and discard the kit lot; complete & return the Field Correction Effectiveness Check/Product Replacement Form attached to this letter within 30 days; Review your inventory of these products to determine your laboratorys replacement needs and to provide information to Siemens for reporting to the authorities. For questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide in the state of Colorado and Foreign distribution to the following countries: Austria, Brazil, Canary Islands, Chile, China, Czech Republic, France, Germany, Great Britain (UK), Italy, Kuwait, Latvia, Poland, Saudi Arabia, Spain, Switzerland, Turkey, United Arab Emirates.

Timeline

Recall initiated: 2017-01-11
Terminated: 2018-06-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #152588. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.