Recall Z-2121-2017 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Medtest Holdings, Inc.
Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass vial w/PP black plastic cap.
| Date | May 20, 2017 (initiated May 15, 2014) |
| Status | Terminated |
| Reason | The original mean assigned to the control too high, upon reassignment with additional data the new assigned mean was outside of the originally published range. |
| Root cause | Component design/selection |
| Action | Customers were notified on 05/5/14by sending a technical bulletin (via email, fax, US Mail and posting on website) to all customers and distributors that had received lot 303104 of C7590, lot 303105 of C7591 or C7592 kits with either lot since product was approved to ship. All product shipped after 05/15/2014 included the updated package inserts. Any questions concerning the implementation of the new controls ranges may be directed to Pointe Scientific's Technical Service Department at 1-800-757-5313. Thank you for your continued support of Pointe Scientific. |
| Quantity | 132919 Vol vials |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.