PerkinElmer LAS Inc RESOLVE Systems Neonatal Hemoglobin Test Kits, 2 Catholyte For in vitro diagnostic use. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Hemoglobin Test Kit Catholyte Solution generating false positive results, were distributed.

Recommended Action

Per FDA guidance

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 follow-up with all non-responding customers will take place in 2 weeks.

Distribution

As reported by FDA

AZ, AR, CA, CO, DE, FL, GA, IN, KS, KY, MD, MI, MN, MT, NJ, NY, NC, OH, OK, OR, SC, TX, UT, VA, WA, WI, PR