Beckman Coulter Access Immunoassay Systems, Access Free T4 Thyroxine, REF 33880 (UDI:15099590225834) for use with Access
FDA device recall Z-2237-2020 · posted 2020-06-02 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687, Tg-REF 33860, and TgAbII-REF A32898 displayed significant interference (defined as a result bias greater than +/-10%) at 1,200 ng/mL of biotin.
- Action taken
- On 04/30/2019, an Urgent Medical Device Letter was sent via mail to affected consignees. Customers were instructed to access the updated Instructions for Use (IFU) Limitations and Interferences sections for the six affected Access immunoassays on the firm's website. Additionally they ask customers to do the following: 1) Share the information with laboratory staff and retain the notification as part of their laboratory Quality System documentation. If any of the affected product(s) have been forwarded to another laboratory, they are to provide them with a copy of the Urgent Medical Device Recall letter. 2) Respond within 10 days either electronically (if received communication via email) or manually (complete and return an enclosed Response Form). If there are any questions regarding the notice, contact the Customer Support Center: website: http://www.beckmancoulter.com By phone: call 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, contact the local firm representative.
- Root cause
- Other
- Status
- Terminated
- Product code
- CEC
- Quantity affected
- 1,322,438 units
- Distribution
- US Distribution: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Loui
- Date initiated
- 2019-04-30
- Date posted
- 2020-06-02
- Date terminated
- 2021-12-28
- Location
- Brea, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (K982250) | Beckman Instruments, Inc. | 1998-07-14 |