Recall Z-0047-05 ยท GKA Abnormal Hemoglobin Quantitation
PerkinElmer LAS Inc
RESOLVE Hemoglobin Test Kits packed and distributed under the Perkin Elmer Life and Analytical Sciences label, Kit Codes: FR-9120 - 120 tests per kit; FR-9400 - 360 tests per kit; and FR-9360 - 3600 tests per kit.
| Date | Oct 28, 2004 (initiated Sep 14, 2004) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | The firm contacted their consignees by letter dated 9/14/04. |
| Quantity | 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, WV )and worldwide (to 12 foreign accounts). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K840011 | RESOLVE-HB Isolab, Inc., Feb 4, 1984 |