Recall Z-1384-2022 ยท PPM General Purpose Reagent
Agilent Technologies, Inc.
Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-21 Vial Labels: Mat. No K589911-21512
| Date | May 20, 2022 |
| Status | Open, Classified |
| Reason | Label provided for substrate vail contained incorrect expiration date. |
| Root cause | Labeling Change Control |
| Action | On 05/20/2022 and 05/27/2022, Agilent Technologies, Inc. had conference calls with the two Medical Laboratory Facilities that were distributed the affected product to inform them of the situation of the incorrect expiration date on the substrate vials (incorrect expiration dated of 6-30-22. The correct expiration date should be 4-30-22 Customer are instructed/informed: - To immediately cease using Anti-FITC-AP CISH Accessory Kit Lot Numbers 06586309 and 06646626, and to return any remaining labels to Agilent, and return any unused kits to Agilent. - That Agilent is completing production of a |
| Quantity | 63 kits |
| Distribution | U.S. Nationwide distribution in the states of NY and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.