Recall Z-0065-2008 ยท LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Bio-Rad Laboratories
Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit, Catalog # 26174, manufactured by Bio-Rad Laboratories, Redmond, WA.
| Date | Oct 31, 2007 (initiated Sep 5, 2007) |
| Status | Terminated |
| Reason | Incorrect Instruction: the package insert states to add 100L of conjugate; it should state to add 100uL. |
| Root cause | Error in labeling |
| Action | On 9/5/07 a letter titled "IMPORTANT PRODUCT INFORMATION" was sent to customers advising them of the issue and requesting customers make a note of the correction in their laboratory procedures and/or any existing copies of the package insert. On 9/19/07 the firm sent a second letter (dated 9/18/07) via DHL titled "URGENT PRODUCT CORRECTION" and supplied a corrected package insert to replace the original insert sent. |
| Quantity | 46 |
| Distribution | Nationwide: Kits were distributed to 27 hospitals, clinics and testing labs throughout the US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.