Recall Z-1840-2015 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Bio-Rad Laboratories, Inc.
The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately from the MONOLISA Anti-HBs EIA Kit contains an expiration date of 2016-04-30 in error.
| Date | Jun 25, 2015 (initiated May 13, 2015) |
| Status | Terminated |
| Reason | The spare component Anti-HBs Cutoff Calibrator, Catalog number 26154, is recalled because the expiration date of 2016-04-30 printed on label in error. |
| Root cause | Incorrect or no expiration date |
| Action | Bio-Rad Laboratories Inc, sent an Urgent Product Correction letter dated May 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The recalled calibrator is a spare component which is sold separately from the MONOLISA Anti-HBs EIA Kit and the kit is not affected by this recall. Customers were informed that testing was performed and the Anti-HBs 10 mLU/mL Calibrator was acceptable to use through the expiration date of the kit dated 2015-11-30. Customers with questions can call the firm at 1-800-224-6723, opti |
| Quantity | 20 vials |
| Distribution | US Distribution to the states of : AZ, CA, ID, MO, and NH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.