Recall Z-0106-2019 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
Helena Laboratories, Inc.
"Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation of free and total Protein antigen in citrated human plasma Contains: 96 Protein S: Ag Microwells, 3 x 0.5mL ELISA Reference Plasma, 1x12 mL Protein S Conjugate Solution, 1 x 60mL Sample Diluent, 1 x 13mL Substrate, 1 x 15mL Stopping Solution, 1 x 30mL Phosphate Buffered Saline, 1 x 2mL Free Protein S Reagent FOR
| Date | Apr 4, 2017 |
| Status | Terminated |
| Reason | Internal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mislabeled. The Protein S Conjugate Solution is labeled as Substrate, and the Substrate is labeled as Protein S conjugate. |
| Root cause | Labeling mix-ups |
| Action | On 4/4/17, an email notification was initially sent to the firm's OUS distributor that received 3 kits. On 4/10/17, the customer replied with a photograph to confirm their kits were affected. A Withdrawal notice was approved internally, and formally issued by the firm to a single distributor via e-mail on 4/17/17. An authorized confirmation of destruction was sent from the distributor to the firm via e-mail on 4/18/17. The firm's public contact may be reached at (409) 842-3714 ext. 1177. |
| Quantity | 3 kits |
| Distribution | International distribution to country of: Jordan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972482 | REAADS PROTEIN S ANTIGEN TEST KIT Reaads Medical Products, Inc., Aug 13, 1997 |