RESOLVE Systems Neonatal Hemoglobin Test Kits, 2 Catholyte For in vitro diagnostic use.

FDA device recall Z-1158-04 · posted 2004-07-23 · Terminated

Recall details

Recalling firm

PerkinElmer LAS Inc

Reason for recall

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

Action taken

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.

Root cause

Other

Status

Terminated

Product code

JBD

Quantity affected

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.

Date initiated

2004-06-29

Date posted

2004-07-23

Date terminated

2008-10-29

Location

Norton, OH

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