Healthmark Protein Test Recalled Due to Expired Ingredient
Healthmark is recalling ProChek protein tests because they were manufactured with an expired ingredient, which may cause false negative or positive results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where the hazard is inaccurate diagnostic results (false positives/negatives) due to an expired ingredient, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Healthmark Industries Co., Inc. is recalling 53 units of the ProChek-W Protein Test for Robotic Arms and the ProChek-Semi Quantitative Protein Test (Model Number PT-SQ-001). The recall is being conducted because the tests were manufactured with an expired ingredient.
The use of the expired ingredient may result in false negative or false positive test results. The affected units are identified by serial or lot numbers 200035, 200036, 200037, 200038, 200039, 200040, and 30028.
The products were distributed worldwide, including the United States, Canada, France, Hong Kong, and South Korea. Consumers and healthcare facilities should stop using the affected products and contact Healthmark Industries Co., Inc. for further instructions.
The recalled product
- Product
- healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001
- Manufacturer
- Healthmark Industries Co., Inc.
- Category
- Medical Device — Diagnostic Test
- Hazard
- Affected units
- 53
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 (7)
- Serial/Lot Numbers: 200035
- 200036
- 200037
- 200038
- 200039
- 200040
- 30028.
Distribution
Distributed nationwide across the United States.
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