Recall Z-1902-2012 ยท LDP Colorimetry, Acetaminophen
Sekisui Diagnostics Llc
MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in human serum or plasma.
| Date | Jun 27, 2012 (initiated May 29, 2012) |
| Status | Terminated |
| Reason | Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery. |
| Root cause | Storage |
| Action | 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. |
| Quantity | 1600 kits |
| Distribution | Illinois |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042330 | ACETAMINOPHEN-SL ASSAY Diagnostic Chemicals , Ltd., Jan 7, 2005 |