Medical Device Recalls

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Product Description	Recall Class	FDA Recall Posting Date	Recalling Firm
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Hemo-Drop Blood Dispenser, Part Number BMP-HEMODROP, used for preparing blood samples.	3	11/05/2019	Biomedical Polymers, Inc.
Manual Diff Dropper, Part Number CHB4001, used for preparing blood samples.	3	11/05/2019	Biomedical Polymers, Inc.
SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemo...	3	11/05/2019	Helena Laboratories, Corp.
OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly...	3	10/18/2019	Xintec Corp
Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the qu...	3	10/16/2019	Roche Diagnostics Operations, Inc.
Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro...	3	10/16/2019	Roche Diagnostics Operations, Inc.
EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100; (b) PHARMACY PACK, RE...	3	10/07/2019	Baxter Healthcare Corporation
Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Pr...	3	10/02/2019	CooperSurgical, Inc.
Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Syst...	3	09/30/2019	ELITech Group B.V.
Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in ...	3	09/23/2019	Randox Laboratories Ltd.

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