Z-1001-2015Class II

PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4...

Name: Z-1001-2015 PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4...
Creator: Genetic Testing Institute,inc
Published: 2014-12-15
License: https://open.fda.gov/license/

Immucor GTI Diagnostics, Inc. / initiated 2014-12-15 / Terminated / root cause: manufacturing process

FDA source

Genetic Testing Institute,inc began a recall of PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13G, HAT45G) and 2... on 2014-12-15. FDA classified it as Class II and gives the reason as "Some Lots of PF4 Concentrated Wash (10X) are a slightly more dilute concentration. This may lead to slightly increased Optical Density (OD) values. Samples with a higher background reactivity may demonstrate false...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1001-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-15
Posted: 2015-01-20
Terminated: 2015-04-30
Recalling firm: Immucor GTI Diagnostics, Inc.
Product: PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13G, HAT45G) and 2. ImmucorGamma LIFECODES PF4 Enhanced (catalog numbers X-HAT13, X-HAT45) The PF4 IgG assay is an Enzyme Linked Immunosorbent Assay (ELISA). The PF4 IgG ELISA is intended to detect IgG antibodies in human serum that react with Platelet Factor 4 (PF4) when it is complexed to heparin or other polyanionic compounds. The PF4 IgG kit contains all of the reagents necessary to perform the assay.
Product code: LCO Platelet Factor 4 Radioimmunoassay
Reason for recall: Some Lots of PF4 Concentrated Wash (10X) are a slightly more dilute concentration. This may lead to slightly increased Optical Density (OD) values. Samples with a higher background reactivity may demonstrate false positive result (borderline reactivity) at or near the cutoff for the assay.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Immucor sent an Urgent - Field Safety Notice letter dated December 15, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised to stop using the recalled product and to destroy it. Requested consignees to complete the Customer Response From and return to [email protected]. Please contact Technical Support should you need additional information at 262.754.1000 or [email protected].
Quantity in commerce: 6206 kits
Distribution: Worldwide Distribution - Nationwide Distribution to the states of : AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN,TX, UT, VA, WA, WV and WI., and the countries of : Canada, Japan, Belgium, European Union , Australia, Taiwan, Thailand and Scotland. ( some countries not yet identified )
Product codes and lots: Reagent Lot Numbers: 3001620, 3001987, 3002083, 3002153

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1001-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1001-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-28	2015-01-20

Product code LCO

K053559Class IIPf4 Enhanced Solid Phase ElisaGenetic Testing Institute / cleared 2006-01-20

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)