—#139264

Product

Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems.

FDA product code: MSW — System, Test, Thyroglobulin
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K002905, K031269
Affected lot / code info: Catalogue number: 33860 Lot numbers: 431990 434727 430969 522896 523251 Expiration date: 10/31/16 12/31/16 08/31/16 04/30/17 05/31/17

Why it was recalled

Beckman Coulter, Inc. is recalling Access Thyroglobulin reagent packs because some may exhibit greater than 10% imprecision at concentrations <10 ng/mL.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On 07/28/2015 the firm sent out customer notification letters via first class mail and e-mail. The firm's letter contained the following instructions: 1. Discard all Access Thyroglobulin reagent pack lots listed in the letter. 2. Evaluate Access Thyroglobulin results <10 ng/mL when using the reagent pack lot numbers listed to determine if controls and/or patients were higher than expected or did not match the clinical status of the patient. 3. At the discretion of the Laboratory Director, notify clinicians that it is possible the Access Thyroglobulin sample results reported by the laboratory were affected by this issue. The firm's notification letter requests that the information be shared with laboratory staff. If any affected products have been forwarded provide a copy of the letter to them. The firm requests that customers complete and return the Response Form within 10 days. Any questions contact the Customer Care Center: 1. From website at http://www.beckmancoulter.com 2. By phone: call 1-800-854-3633 in the United States and Canada. 3. Outside the United States and Canada, contact local Beckman Coulter representative

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Algeria, Australia, Austria, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Egypt, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Lebanon, Lithuania, Mexico, Morocco, New Zealand, Oman, Philippines, Portugal, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Vietnam and Yemen.

Timeline

Recall initiated: 2015-07-28
Posted by FDA: 2015-09-03
Terminated: 2016-04-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #139264. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.