Recall Z-1158-04 ยท JBD System, Analysis, Electrophoretic Hemoglobin
PerkinElmer LAS Inc
RESOLVE Systems Neonatal Hemoglobin Test Kits, 2 Catholyte For in vitro diagnostic use.
| Date | Jul 23, 2004 (initiated Jun 29, 2004) |
| Status | Terminated |
| Reason | Hemoglobin Test Kit Catholyte Solution generating false positive results, were distributed. |
| Root cause | Other |
| Action | The firm contacted their customers via telephone and notified them of the recall on 6/29/2004. A follow-up recall letter was also issued on 6/29/2004. The letter requests that the customer either destroy the product or return it to the firm for replacement. Also attached for completion and to be faxed back to the recalling firm, is a questionaire which documents the customer''s receipt of the product and recall letter; any reports of illness or injury in connection with the use of the product; and the customer''s proposed disposition of the kits i.e. return or destruction. Additional follo |
| Quantity | 146 |
| Distribution | The recalled kits were distributed to customers in the following locations: FL, OK, GA, MD, AZ, KY, NY, PR, OR, NJ, WA, MI, KS, AR, IN, TX, MN, CA, VA, NC, DE, UT, WI, SC, OH, MT, KS, CO & PR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K840011 | RESOLVE-HB Isolab, Inc., Feb 4, 1984 |