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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Cell Marque Corporation: Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.

Agency Publication Date: June 1, 2017
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Affected Products

Product: Adenovirus (20/11 & 2/6); 0.5 mL Catalog # 212M-15; and 7.0 mL Catalog number 212M-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

0.5 mL - 1318203P , Expiry 2018-04; 7.0 mL - 1318204H 201, Expiry 8-04 11 and 1532111A, expiry 2018-10.

Product: Estrogen Receptor (EP1) 7.0 mL Catalog number 249R-28; 1.0 mL Catalog number 249R-16 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

7.0 ml lot 1326605C; expiry 2018-06; 1.0 ml lot 14035068; expiry 2017-01.

Lot Numbers:
1326605C
14035068
Product: Estrogen Receptor (SP1) 7.0 mL Catalog number 249R-18; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

7.0 ml lot 1603506A , expiry 201 9-01; lot 1422402D/1422402L, expiry 2017-07.

Lot Numbers:
1603506A
1422402D
Product: H. pylori (polyclonal} 1.0 mL Catalog number 215A-76; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

1.0 ml lot 1611307C, expiry 201 9-03.

Lot Numbers:
1611307C
Product: Her2/Neu (c-erbB-2) (CB-1 1); 7.0 mL Catalog number 237M-18. In vitro diagnostic use - Analyte Specific Reagent Immunology - Analyte Specific Reagent

7.0 ml lot 11515602A, expiry 2018-05.

Lot Numbers:
11515602A
Product: Her2/Neu (EP3); 0.5 mL Catalog number 237R-25; 1.0 mL Catalog number 237R-26; 7.0 mL Catalog number 237R-28. Immunology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

0.5 ml lot 1418111A , expiry 2017-05; 1.0 ml lot, 1619706E , expiry 2019-06; 7.0 ml lot 1418112A, expiry 2017-05; lot 14181, expiry 12G 2017-05.

Lot Numbers:
1418111A
1418112A
14181
Product: Herpes Simplex Virus I; 7.0 mL Catalog number 361A-18. Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

7.0 ml lot 1432301A, expiry 2017-10; lot 1525206A , expiry 201 8-08.

Lot Numbers:
1432301A
1525206A
Product: Herpes Simplex Virus II 0.5 ml catalog number 362A-15 7.0 mL Catalog number362A-18 . Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

0.5 ml lot 1512811A, Expiry 201 8-04; 7.0 ml lot 1512810E, expiry 2018-04.

Lot Numbers:
1512811A
1512810E
Product: SV40 (MRQ-4) 0.5 ml catalog number 351 M-15. Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

lot 1416002H, expiry 2017-05

Lot Numbers:
1416002H
Product: Varicella Zoster Virus 7.0 ml catalog number 364M-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

7.0 ml lot 15261038, Expiry 2018-08

Lot Numbers:
15261038
Product: CD117, c-kit (YR145) 1.0 ml catalog number 117R-16 7.0 ml catalog number-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

1.0 ml lot 16175038, expiry 2019-05; 7.0 mL lot 1617502A, expiry 2019-05; lot 16175020, expiry 2019-05 and lot 1511403J, expiry 2018-03.

Lot Numbers:
16175038
1617502A
16175020
1511403J
Product: HHV-8 (13810); 1.0 ml catalog number 265M-16; 7.0 ml catalog number-265M-18; Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

1.0 ml lot 1626403D, expiry 2019-08; 7.0 mL lot. 1625207H, expiry 2019-08;

Lot Numbers:
1626403D

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 77209
Status: Resolved
Manufacturer: Cell Marque Corporation
Manufactured In: United States
Units Affected: 10 products (12; 8; 5; 10; 3; 2; 3; 1; 12; 11)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.