Medtest Liquid Creatine Kinase Reagent Set Recalled for Labeling Mismatch
Medtest Holdings is recalling Pointe Scientific Liquid Creatine Kinase Reagent Sets because the product insert does not match the approved premarket notification.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a documentation mismatch, fitting the 'Low' severity criteria for documentation issues.
Plain-English summary
Medtest Holdings, Inc. is recalling Pointe Scientific Liquid Creatine Kinase Reagent Sets. The device is a kit comprised of two reagents, R1 Buffer and R2 CK enzyme solution, intended for the kinetic quantitative determination of creatine kinase activity in serum. The recall involves models C7522, HC422, HC722, and HC922 with specific lot numbers and expiration dates ranging from July 2012 to September 2013.
The recall was initiated because the linear performance information in the product insert does not match that listed in the approved premarket notification. This is a documentation and labeling discrepancy rather than a report of product failure or patient injury.
The affected products were distributed nationwide. Users of these reagent sets should contact Medtest Holdings, Inc. for further instructions on how to handle the recalled items.
The recalled product
- Product
- Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.
- Manufacturer
- Medtest Holdings, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Models: C7522
- HC422
- HC722
- HC922. Lot#'s: 020902
- 029902 R1
- 029902 R2
- 029903
- 113204
- 129403
- 209001. Exp dates 7/2012 to 9/2013.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Medtest Holdings, Inc.
See all →- LowMedtest AutoHDL/LDL Cholesterol Calibrator Recalled for Missing Vial Labels
FDA (Devices) · 2018-11-14
- LowMedtest CRP Calibrator and Standard Sets Recalled for Unit Mislabeling
FDA (Devices) · 2017-07-05
- LowMedtest Holdings Recalls CK-MB Control Kits Due to Labeling Error
FDA (Devices) · 2017-07-05
- ModerateMedtest Recalls Pointe Scientific Hitachi Total Bilirubin R1 Reagent
FDA (Devices) · 2017-06-21
- LowMedTest DX Assayed Human Multi Sera Control Recall for Out-of-Spec Values
FDA (Devices) · 2017-06-14
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
Similar recalls
- LowPointe Scientific Creatinine Reagent Recall Due to Labeling Error
FDA (Devices) · 2015-09-23
- ModeratePointe Scientific Lactate Dehydrogenase Reagent Set Recalled for Stability Issues
FDA (Devices) · 2017-06-07
- LowMedtest Holdings Recalls Pointe Scientific Hitachi AST Reagent Due to Labeling Discrepancy
FDA (Devices) · 2017-05-24
- LowMedtest Holdings Recalls CK-MB Control Kits Due to Labeling Error
FDA (Devices) · 2017-07-05
- HighMedtest Homocysteine Reagent Recalled for Performance Deterioration
FDA (Devices) · 2016-07-06
- HighRoche Creatine Kinase test reagents recalled for calibration errors
FDA (Devices) · 2024-10-02