Healthmark ProChek-II Medical Tests Recalled for Expired Ingredient
Healthmark Industries is recalling ProChek-II 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 medical device that may produce false diagnostic results (false negative or positive), which poses a risk of harm to patients by potentially leading to incorrect medical decisions, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Healthmark Industries Co., Inc. is recalling 5,090 units of healthmark ProChek-II tests, Model Numbers PT-313 and PT-201-12. The recall is due to the use of an expired ingredient during the manufacturing process.
The affected tests may present as either a false negative or a false positive. The recall covers units distributed worldwide, including the United States, Canada, France, Hong Kong, and South Korea.
Consumers should stop using the affected tests and contact Healthmark Industries for further instructions or a replacement. Specific serial and lot numbers are listed in the official recall documentation.
The recalled product
- Product
- healthmark ProChek-II, Model Number PT-313, PT-201-12
- Manufacturer
- Healthmark Industries Co., Inc.
- Category
- Medical Device — Diagnostic Test
- Affected units
- 5,090
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 (20)
- PT-313 - Serial/Lot Numbers: 3000535312
- 3000535333
- 3000536416
- 3000536423
- 3000537810
- 3000537822
- 3000542453
- 3000545623
- 3000550099
- 3000550512
- 313069
- 313072
- 313073
- 313074
- 313075
- 313076
- 313077
- 313078
- 313079
- 313080
Distribution
Distributed nationwide across the United States.
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