The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1345-2013·Announced 2013-05-29

Technidata TD-Synergy Laboratory Information System Software Recall

Technidata is recalling TD-Synergy Laboratory Information System software because a specific keyboard shortcut can modify previously entered test 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 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: The recall is classified as FDA Class II, and the hazard involves a software defect that can modify data values. No injuries, illnesses, or deaths are reported, and the risk is related to data integrity rather than direct physical harm, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Technidata S.A. is recalling TD-Synergy Laboratory Information System software. The recall involves 10 units of the software distributed nationwide in the United States, including Washington DC, California, Nevada, Kentucky, Alabama, Rhode Island, Pennsylvania, and Louisiana, as well as in Italy.

The recall was initiated because Technidata discovered that using the F8 key in the ERM session to add a combined test can result in the modification of the value of a result that has already been entered for a test of the request. This defect could lead to incorrect data being recorded in the laboratory information system.

Affected users should contact Technidata for further instructions on how to resolve the issue. The specific software versions affected include various LIS and TD-Synergy versions listed in the recall documentation.

The recalled product

Product
TD-Synergy. Laboratory Information System.
Manufacturer
Technidata S.A.
Category
Medical Device — Laboratory Software
Hazard
Affected units
10

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 (9)

  • TD Lims product versions: LIS (ALLX)-21.041-_ML-5370
  • LIS (ALLX)-22.021-_ML-5374
  • TD-Synergy product versions: SYN (ALLX)- 03.13B-_ML-5368
  • SYN (ALLX)- 03.141-_ML-5369
  • SYN(LINUX)-06.011-_ML-5381
  • SYN (ALLX)-11.11B-_ML-5345
  • SYN (ALLX)-11.21B-_ML-5346 SYN (ALL)- 11.31C-_ML-5372
  • SYN (LINUX)-11.321-_FR-5382
  • SYN (ALL)-11.321-_ML-5373

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

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