Remel VersaTREK Instrument Series 528 Recalled for False Positive Reports
Remel Inc. is recalling 21 VersaTREK Instrument Series 528 devices because their use may result in false positive reports.
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 and involves a risk of harm (false positive reports) where specific injury or illness has not been reported, fitting the High severity criteria.
Plain-English summary
Remel Inc. is recalling 21 units of the VersaTREK Instrument Series 528 (REF 6528). This medical device is used for cultivating and recovering microorganisms, particularly bacteria and yeasts, from blood and other normally sterile bodily fluids.
The recall was initiated because the use of the recalled product may result in false positive reports. The agency has classified this recall as Class II.
The affected devices were distributed worldwide, including in the United States (AZ, CO, FL, GA, IA, ID, LA, MI, MO, PR, TN, TX, VA, and WA) and in Canada, China, Egypt, Finland, France, Indonesia, Israel, Jordan, Kenya, Republic of Korea, Latvia, Romania, Russia, Spain, Thailand, United Kingdom, Uruguay, and Vietnam. Users should stop using the affected devices and contact Remel Inc. for instructions.
The recalled product
- Product
- VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.
- Manufacturer
- Remel Inc
- Hazard
- Affected units
- 21
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)
- Serial numbers: 0169050501141020
- 0169059801141031
- 0169064701141210
- 0169066801150105
- 2200X1113
- 2215X1113
- 2236X1213
- 2244X1213
- 2272X0214
- 2273X0214
- 2274X0214
- 2275X0214
- 2298X0714
- 2299X0714
- 2300X0714
- 2301X0714
- 2303X0714
- 2304X0714
- 2326X0814
- 2327X0814
Distribution
Part of a larger recall action
This product is one of 2 recalled by Remel Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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