openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 12
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
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
0.5 mL - 1318203P , Expiry 2018-04; 7.0 mL - 1318204H 201, Expiry 8-04 11 and 1532111A, expiry 2018-10.
Distribution pattern
Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
device · product 2 of 12
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
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
7.0 ml lot 1326605C; expiry 2018-06; 1.0 ml lot 14035068; expiry 2017-01.
Distribution pattern
Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
device · product 3 of 12
Estrogen Receptor (SP1) 7.0 mL Catalog number 249R-18; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
7.0 ml lot 1603506A , expiry 201 9-01; lot 1422402D/1422402L, expiry 2017-07.
Distribution pattern
Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
device · product 4 of 12
H. pylori (polyclonal} 1.0 mL Catalog number 215A-76; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
1.0 ml lot 1611307C, expiry 201 9-03.
Distribution pattern
Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
device · product 5 of 12
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
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
7.0 ml lot 11515602A, expiry 2018-05.
Distribution pattern
Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
device · product 6 of 12
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
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
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.
Distribution pattern
Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
device · product 7 of 12
Herpes Simplex Virus I; 7.0 mL Catalog number 361A-18. Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
7.0 ml lot 1432301A, expiry 2017-10; lot 1525206A , expiry 201 8-08.
Distribution pattern
Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
device · product 8 of 12
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
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
0.5 ml lot 1512811A, Expiry 201 8-04; 7.0 ml lot 1512810E, expiry 2018-04.
Distribution pattern
Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
device · product 9 of 12
SV40 (MRQ-4) 0.5 ml catalog number 351 M-15. Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
lot 1416002H, expiry 2017-05
Distribution pattern
Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
device · product 10 of 12
Varicella Zoster Virus 7.0 ml catalog number 364M-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
7.0 ml lot 15261038, Expiry 2018-08
Distribution pattern
Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
device · product 11 of 12
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
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
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.
Distribution pattern
Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
device · product 12 of 12
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
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
1.0 ml lot 1626403D, expiry 2019-08; 7.0 mL lot. 1625207H, expiry 2019-08;
Distribution pattern
Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
