FDAClass IIJune 21, 2017

Pointe Scientific Hitachi Total Bilirubin Rl Reagent recall

Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent Hitachi Total Bilirubin Rl Reagent is used with Hitachi…

Why was Pointe Scientific Hitachi Total Bilirubin Rl Reagent recalled?

Decrease reactivity of R 1 component.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog # HB979-693 Lot #'s: 025903-012; 025903-278. Catalog # HB979-711 Lot #'s: 025903-009; 025903-079; 025903-080; 025903-102; 025903-278; 025903-355. Catalog # 7-HB979-R1-40 Lot #: 025903-055. Catalog # 12-HB979-192 Lot #'s: 025903-090; 025903-362.

Product
Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent Hitachi Total Bilirubin Rl Reagent is used with Hitachi…
Recalling firm
Medtest Holdings, Inc.
Quantity
270.36 L
Distribution
Worldwide Distribution in the states of IL, PR, CA, OR, MI, FL, NY, TX, OK, GA, VA and country of CHILE
Recall date
June 21, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls