FDAApril 20, 2020device
Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant woman is positive for GBS colonization, this will indicate a need for treatment prior to vaginal d...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdiagnosis of the patient.
What to do
FDA enforcement status: Terminated
Brands named
cardinal healthcardinal
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCDiamond Wipes International Recalls CVS Health Medicated Hemorrhoidal Wipes Due to Risk of Serious Injury or Death from Child Poisoning; Violate Mandatory Standard for Child-Resistant Packaging2026-07-02
- FDABuprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufactured for: Endo USA, Malvern, PA 19355, NDC 42023-179-052026-06-12
- FDAPrimidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-112026-05-01
- FDAPrimidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-112026-05-01
- FDAVitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 mL per oral syringe, (Nephronex), Mfg By: LLORENS; Pkg by: Safecor, Columbus, OH. NDC 54859-0516-082026-05-01
- CPSCAdult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed Rails; Imported by Hepo Care Medical Equipment Online2026-04-30
- FDAAtomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204. NDC: 64380-474-012026-04-30
- FDAOptase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile, Manufactured for Scope Health Inc., 79 Madison Ave., 8th Floor, New York, NY 10016, USA, NDC 72972-002-01.2026-04-20
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