RESOLVE Hemoglobin Test Kits packed and distributed under the Perkin Elmer Life and Analytical Sciences label, Kit Codes
FDA device recall Z-0047-05 · posted 2004-10-28 · Terminated
Recall details
- Recalling firm
- PerkinElmer LAS Inc
- Reason for recall
- The product insert for the test kits is incorrect with regard to the acceptable storage temperature for the Agarose IEF gel component. The kit and IEF gel labels indicate the correct storage temperature of 2-8 degrees C. The product insert incorrectly indicates that the product may be stored at 2-30 degrees C.
- Action taken
- The firm contacted their consignees by letter dated 9/14/04.
- Root cause
- Other
- Status
- Terminated
- Product code
- GKA
- Quantity affected
- All lots of test kits manufactured by the firm which have an active shelf life are subject to recall.
- Distribution
- Nationwide (The product was distributed to firms located in AR, AZ, CA, CO,FL, GA, HI, IA, IL, IN, KS, KY,LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI
- Date initiated
- 2004-09-14
- Date posted
- 2004-10-28
- Date terminated
- 2008-10-29
- Location
- Norton, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RESOLVE-HB (K840011) | Isolab, Inc. | 1984-02-04 |