in2it (I) A1c Test Cartridges (Catalog 281-0001EX) and in2it (II) A1c Test Cartridges (Catalog 281-0001), manufactured b
FDA device recall Z-0109-2011 · posted 2010-10-21 · Terminated
Recall details
- Recalling firm
- Bio-Rad Laboratories Inc
- Reason for recall
- Test Cartridges may leak and have the potential to generate error messages and biased inaccurate results.
- Action taken
- BIO-RAD Laboratories Deeside sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated September 7, 2010, via registered mail to all subsidiaries/customers. The letter described the product, problem and actions to be taken by the customer. The customers were instructed to stop using and discard the test cartridges from the listed lots; complete and return the attached CUSTOMER MEDICAL DEVICE CORRECTION RESPONSE FORM via fax +44 1244 833401; record the number of affected kits of product, confirm that they have discarded the cartridges and record the method of disposal. If you have any questions, contact +44 1244 288888.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- LCP
- Quantity affected
- 4056
- Distribution
- Worldwide distribution: USA and countries including: Australia, New Zealand, Taiwan, France, the UK, Singapore, Germany, Italy, Thailand, China, Korea, Sweden, Sri Lanka, Maldives, Canada and the Phil
- Date initiated
- 2010-09-07
- Date posted
- 2010-10-21
- Date terminated
- 2011-05-17
- Location
- Hercules, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| G5 I HBA1C TEST, G5 II HBA1C TEST (K041635) | Provalis Diagnostics , Ltd. | 2004-08-16 |