Medical microscope slide stainer recalled due to defective pump tubing
Hardy Diagnostics is recalling the Quickslide GramPro 1 Automated Gram Stanier due to defective tubing in the pump mechanism that could cause device malfunction.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II device recall without any reported illnesses, injuries, or property damage. The hazard is a manufacturing defect in a device component that represents a malfunction risk but lacks evidence of direct patient harm.
Plain-English summary
Hardy Diagnostics is recalling the Quickslide GramPro 1 Automated Gram Stanier, an automated microscope slide staining device, due to the use of defective tubing in the pump mechanism during assembly and servicing.
The defective tubing could affect the device's ability to function properly during use. A total of 69 units were distributed nationwide.
Affected units are identified by lot numbers 1654, 1657, 1658, 1660, 1661, 1662, and 1663. A complete list of affected serial numbers is available from the FDA recall information. Customers who have units within the affected lot numbers should contact Hardy Diagnostics for instructions on remedy.
The recalled product
- Product
- Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.
- Manufacturer
- Hardy Diagnostics
- Affected units
- 69
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)
- Lot Numbers: 1654
- 1657
- 1658
- 1660
- 1661
- 1662
- 1663. Serial Numbers: 354
- 417
- 422
- 462
- 472
- 473
- 480
- 488
- 490
- 491
- 496
- 503
- 505
- 513
Distribution
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