MassTox Reagent Kit LC-MS/MS Anal of Antidepres/Neuroleptic in Serum/Plasma (2020-03-12)

Starting date:

March 12, 2020

Posting date:

April 17, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-72789

Last updated: 2020-04-17

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  Reason
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  Affected products

Affected Products

MassTox Reagent Kit LC-MS/MS Anal of Antidepres/Neuroleptic in Serum/Plasma

Reason

Internal investigations demonstrate that existing lot #2219 on the market of multilevel plasma calibrator set neuroleptics 1/extended 92028/xt and neuroleptics 1/extended plasma control level i 0211/xt und level ii 0212/xt does not meet the stability criteria after 3 days at +2 to +8 ?C for olanzapine and n-desmethylolanzapine after reconstitution with water as specified in the instruction for use.

Affected products