MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white seal plu
FDA device recall Z-2768-2015 · posted 2015-09-15 · Terminated
Recall details
- Recalling firm
- MedtestDx, Inc.
- Reason for recall
- Vial to vial variation in the fill volume that could affect control recovery issues and cause a control result to fall outside the suggested recovery ranges. An under-fill of the vials was found ranging as low as 4.63 ml. When used to reconstitute HNC/HEC, control values were shown to be out of range running on the high end.
- Action taken
- On 5/15/2015, MedTest DX Field Correction Notice notifications were sent to the affected customers via electronic mail and US mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Any questions concerning the corrective action may be directed to MedTest Technical Service Department at 1-800-757-5313.
- Root cause
- Process design
- Status
- Terminated
- Product code
- JJY
- Quantity affected
- 79 kits
- Distribution
- US Nationwide Distribution.
- Date initiated
- 2015-05-15
- Date posted
- 2015-09-15
- Date terminated
- 2016-05-23
- Location
- Canton, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATED (K942458) | Randox Laboratories, Ltd. | 1995-03-13 |