FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for the determination of Vitamin D The
FDA device recall Z-0550-2014 · posted 2013-12-19 · Terminated
Recall details
- Recalling firm
- Qualigen Inc
- Reason for recall
- Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.
- Action taken
- Qualigen, Inc., notified customers of the recall by calling customers via telephone (with a telephone script) on 11/08/2013. The telephone (script) included the reason for recall, product description with codes, instructions and contact information. The customers were instructed to examine your inventory and discontinue use of the kits immediately. Qualigen will send you replacement kits and provide you with a shipping label to return all of the defective kits including any that were partially used. Feel free to contact System Support at 760.579.6900 if you have any questions or require assistance with returning your kits.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- MRG
- Quantity affected
- 6
- Distribution
- US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.
- Date initiated
- 2013-11-08
- Date posted
- 2013-12-19
- Date terminated
- 2014-09-18
- Location
- Carlsbad, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS (K123983) | Qualigen, Inc. | 2013-07-03 |