JAS Diagnostics Recalls Drew Scientific DREW 3-PAC Reagent Kits
JAS Diagnostics Inc. is recalling 14,064 units of Drew Scientific DREW 3-PAC Reagent Kits because they may result in elevated platelet backgrounds during routine startup checks.
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 is classified as FDA Class II. The hazard involves potential diagnostic errors (elevated platelet backgrounds) which may lead to temporary or medically reversible adverse health consequences, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
JAS Diagnostics Inc. is recalling 14,064 units of the Drew Scientific DREW 3-PAC Reagent Kit. The kits contain 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent. The recall is due to a defect where the product may result in elevated platelet backgrounds during routine startup and background checks.
The affected lots include #0868 (exp. 11/28/2018), #0869 and #0870 (exp. 01/10/2019), #0871 through #0876 (exp. 02/06/2019), and #0877, #0879, #0880, #0881, and #0882 (exp. 02/23/2019). The products were distributed to various locations in the United States, Puerto Rico, and several international countries including the United Arab Emirates, Bolivia, and Italy.
This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Users should stop using the affected reagent kits and contact JAS Diagnostics Inc. for instructions on return or replacement.
The recalled product
- Product
- Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
- Manufacturer
- JAS Diagnostics Inc.
- Hazard
- Affected units
- 14,064
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 (14)
- Lot # 0868 Exp. Date 11/28/2018
- Lot # 0869 & Lot 0870 Exp. Date 01/10/2019
- Lot # 0871
- 0872
- 0873
- 0874
- 0875
- and 0876 Exp. Date 02/06/2019
- and Lot # 0877
- 0877
- 0879
- 0880
- 0881
- and 0882 Exp. Date 02/23/2019
Distribution
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