Reported Sep 23, 2015 · Terminated
MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white seal…
MedtestDx, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MedtestDx, Inc. · 5449 Research Dr · Canton, MI · 48188-2261
Is this the product you have?
- MedTest DX Control
- Reconstitution Fluid Kit configuration20 x 5 ml
- Bottle5
- ml amber glass Cap18 mm white seal plug seal rubber HC-DIL (Human Control Diluent) is reagent grade water filled into 5ml vials used to reconstitute Human controls HNC200 and HEC200. in vitro diagnostic
- Lot codes and dates
- Catalog numberHC-DIL
- Lot072414-206
- Expiration date2016-07
- Amount recalled
- 79 kits
Where it was sold
- Nationwide
Why it was recalled
Vial to vial variation in the fill volume that could affect control recovery issues and cause a control result to fall outside the suggested recovery ranges. An under-fill of the vials was found ranging as low as 4.63 ml. When used to reconstitute HNC/HEC, control values were shown to be out of range running on the high end.
This product could cause temporary or reversible health problems — stop using it.
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