Z-1158-04

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

Name: Z-1158-04 RESOLVE Systems Neonatal Hemoglobin Test Kits, 2 Catholyte For in vitro diagnostic use
Creator: PerkinElmer LAS Inc
Published: 2004-06-29
License: https://open.fda.gov/license/

Revvity Health Sciences, Inc. / initiated 2004-06-29 / Terminated

FDA source

PerkinElmer LAS Inc began a recall of RESOLVE Systems Neonatal Hemoglobin Test Kits, 2 Catholyte For in vitro diagnostic use on 2004-06-29. The reason FDA records is "Hemoglobin Test Kit Catholyte Solution generating false positive results, were distributed". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1158-04
Status: Terminated
Initiated: 2004-06-29
Posted: 2004-07-23
Terminated: 2008-10-29
Recalling firm: Revvity Health Sciences, Inc.
Product: RESOLVE Systems Neonatal Hemoglobin Test Kits, 2 Catholyte For in vitro diagnostic use.
Product code: JBD System, Analysis, Electrophoretic Hemoglobin
Reason for recall: Hemoglobin Test Kit Catholyte Solution generating false positive results, were distributed.
FDA 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 follow-up with all non-responding customers will take place in 2 weeks.
Quantity in commerce: 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.
Product codes and lots: Catholyte Solution Batch Lot #235867, included in kits labeled with Kit Lot Numbers: 234172, 234177, 234182, 234190, 234195, 234200, 234205, 234222, 234231, 234240, 234247, 234252, 234257, 234262, 234267, 234272, 234277, 238917, 238920 & 238923.

Product code JBD

K840011Class IIResolve-HbIsolab, Inc. / cleared 1984-02-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)