Z-1491-2014Class III

The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analyte Specific Reagent (ASR)...

Name: Z-1491-2014 The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analyte Specific Reagent (ASR)...
Creator: Abbott Molecular
Published: 2013-03-28
License: https://open.fda.gov/license/

Abbott Molecular, Inc. / initiated 2013-03-28 / Terminated / root cause: packaging

FDA source

Abbott Molecular began a recall of The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analyte Specific Reagent (ASR) containing a single vial of CEP 8 spectrum green probe... on 2013-03-28. FDA classified it as Class III and gives the reason as "20 kits of CEP 8 SG ASR Probe (list 06J37-018, lot 440023), contained Vysis CEP 4 (Alpha Satellite) SG Probe, 20u, (part 32-112004 lot 438814), instead of the expected CEP 8 probe". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1491-2014
Classification: Class III
Status: Terminated
Initiated: 2013-03-28
Posted: 2014-04-23
Terminated: 2016-03-08
Recalling firm: Abbott Molecular, Inc.
Product: The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analyte Specific Reagent (ASR) containing a single vial of CEP 8 spectrum green probe and a Certificate of Analysis (COA). Chromosome enumeration probes (CEP) are chromosome-specific FISH probes that hybridize to highly repetitive human satellite DNA sequences, usually located near centromeres. CEP signals enable the identification and enumeration of human chromosomes in interphase and metaphase cells from fresh and archived samples. The label for CEP 8 SG ASR Probe Kit indicates it is an Analyte Specific Reagent, and analytical and performance characteristics are not established.
Product code: MVU Reagents, Specific, Analyte
Reason for recall: 20 kits of CEP 8 SG ASR Probe (list 06J37-018, lot 440023), contained Vysis CEP 4 (Alpha Satellite) SG Probe, 20u, (part 32-112004 lot 438814), instead of the expected CEP 8 probe.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: Customers were sent Field Correction Notices dated 3/28/13 instructing them to inspect their CEP 8 SpectrumGreen Probe kits for the presence of CEP4 probe vials. If any CEP4 vials are discovered, customers should contact their local Abbott Molecular Technical Support Represtative for coordination of reagent replacement with the correct CEP8 vial. If customers have any specific questions they can contact Abbott Molecular at 1-800-553-7042, Option 2.
Quantity in commerce: 20 kits
Distribution: Nationwide (CA, CO, CT, FL, HI, IL, IN, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, TN, TX, VA, WA, WI); Canada
Product codes and lots: List Number: 06J37-018; Lot Number: 440023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1491-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1491-2014	Class III	Terminated	Voluntary: Firm initiated	2014-04-30	2014-04-23

Product code MVU

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)