FDAMarch 13, 2015device

Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2 12-H7545-162 kit includes 3x40 ml of R1 and 3x14 ml of R2 HDL600 kit includes 3x40 ml of R1 and 3x14 ml of R2 Kits: HDPE plastic bottle, PP pl...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen during transport. The crystals do not impact product performance.

What to do

FDA enforcement status: Terminated

Brands named

pointe scientificpointe

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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