AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA Product Usa
FDA device recall Z-2577-2018 · posted 2018-07-13 · Terminated
Recall details
- Recalling firm
- Qiagen Sciences, Inc.
- Reason for recall
- Potential for control line not appearing on the test strip
- Action taken
- On May 18, 2018 QIAGEN issued Urgent Voluntary Medical Device Recall notices and response forms to customers. Customers were advised to take the following actions: 1) Immediately discontinue use of all impacted lots and return all unused product to QIAGEN. 2) Share the Voluntary Medical Device Recall Notice with all users of the AmniSure ROM Test in your facility to ensure they are aware of this recall. 3) Use the Return Response form to confirm receipt of the notification and to record quantity of material to return. If you have any questions regarding this notice, please contact Technical Services at 1-800-344-3631.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- NQM
- Quantity affected
- 1620 kits
- Distribution
- Worldwide - US Nationwide distribution an in the country of , Canada
- Date initiated
- 2018-05-18
- Date posted
- 2018-07-13
- Date terminated
- 2020-09-02
- Location
- Germantown, MD
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1 (K081767) | Amnisure International, LLC | 2009-01-09 |