Culture Media, Non-Propagating Transport
FDA adverse event reports and recall history for culture media, non-propagating transport (product code JSM), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 580
- Deaths
- 1
- Injuries
- 78
- Malfunctions
- 493
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2024-08-14Open, ClassifiedUnder Investigation by firm
Cepheid, Sample Collection Device, Part: 900-0370
Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could result in biohazard exposure, cross contamination causing false positive results for other specimens, and/or delay to test results.
- 2022-10-08Open, ClassifiedNo Marketing Application
COVID Test Kit Nonsterile
Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device.
- 2022-08-26Open, ClassifiedEnvironmental control
a. BECTON DICKINSON BD Vacutainer C&S Preservative Urine Tube TUBE, URINE COLL PLAS 4ML (100/BX 10BX/CS), Model Number: BD 364951. b. BECTON DICKINSON BD Vacutainer C&S Transfer Straw Kit TRANSFER STRAW KIT, URINE 4ML(50/BX 4BX/CS) Model Number: BD 364953. c. BECTON DICKINSON BD Vacutainer COLLECTION KIT, URINE COMPLETE 8ML 13"X75" (50/CS) BD Model Number: 364957
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2022-08-26Open, ClassifiedEnvironmental control
FISHER SCIENTIFIC Fisherbrand SWAB TRANS STUARTS DBL 50BX Catalog #1490721
XXX
- 2022-08-26Open, ClassifiedEnvironmental control
MEDICAL CHEMICAL CORPORATION Total-Fix STOOL COLL KIT, TOTAL FIX PARASITOLOGY (100/CS) Catalog # NC0585129
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2022-07-01Open, ClassifiedProcess control
Clean Catch Urine Kit NS 178489, AHMU58A
Affected products were assembled off-site by individuals who may not have been properly trained.
- 2022-07-01Open, ClassifiedProcess control
Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
Affected products were assembled off-site by individuals who may not have been properly trained.
- 2010-03-15TerminatedPackaging
remel A.C.T. II Sterile Pack Tube, Collection and Transport System, Ref 12402, 10/pk, each Tyvek pouch contains 1 tube of medium and 1 rayon-tipped sterile swab. The firm name on the label is remel, Lenexa, KS. Product is a sterile system recommended for use in qualitative procedures for the collection of clinical specimens and transport to the laboratory for microbiological culture of anaerobic, facultative, and aerobic organisms.
Pouch may be inadequately heat sealed compromising sterility
- 2010-03-08TerminatedOther
BD Vacutainer Urine Cup Kit with C&S Preservative Tube for Midstream specimens; 50; Becton Dickinson and Company, Franklin Lakes, NJ 07417; Kit contains Sterile Screw-Cap collection cup with Integrated Transfer Device and 4.0 mL 13x75mm Plus Plastic C&S Preservative Tube and Castile Soap Towelettes.
A small amount of discoloration was noted on Towelettes included in BD Vacutainer Urine collection kits. The entire kit components retain sterile interiors and no viable growth was detected on the towelettes.
- 2010-03-08TerminatedOther
BD Vacutainer Urine Complete Kit with UA Tube and S&C Preservative Tube for Midstream specimens; Plus Plastic - Sterile Cup and Tube interiors. Store at 4-25 degrees C. Kit contains Sterile Screw CAP Collection Cup with integrated Transfer Device and 8.0 mL, 16/x100 mm PLUS Plastic Conical Tube for Urinalysis and 4.0 mL 13x75mm Plus Plastic C&C Preservative tube and Castile Soap Towelettes; Becton Dickinson and Company, Franklin Lakes, NJ
A small amount of discoloration was noted on Towelettes included in BD Vacutainer Urine collection kits. The entire kit components retain sterile interiors and no viable growth was detected on the towelettes.
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