MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determin
FDA device recall Z-1902-2012 · posted 2012-06-27 · Terminated
Recall details
- Recalling firm
- Sekisui Diagnostics Llc
- Reason for recall
- Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery.
- Action taken
- Sekisui Diagnostics Llc sent an "IMPORTANT PRODUCT FIELD CORRECTION" letter dated May 29, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to immediately stop using the affected product and to destroy any remaining inventory. A Confirmation of Notification Form was attached for customers to complete and return via fax to 902-628-6504. Contact the firm at 902-628-0984 for questions regarding this notice.
- Root cause
- Storage
- Status
- Terminated
- Product code
- LDP
- Quantity affected
- 1600 kits
- Distribution
- Illinois
- Date initiated
- 2012-05-29
- Date posted
- 2012-06-27
- Date terminated
- 2012-11-14
- Location
- Framingham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACETAMINOPHEN-SL ASSAY (K042330) | Diagnostic Chemicals , Ltd. | 2005-01-07 |