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I N F O R M A T I C A |
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FDA Enforcement Related to Automatic Identification Technology |
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Our purpose
in providing this information is to show you that: INFORMATICA always conforms to FDA regulations and JCAHO guidelines to ensure patient safety and confidentiality. |
| These excerpts will contain only the product type and reason for the enforcement activity, which in most cases was a recall. |
| Product: Several
Drug Products Reason: Bar code readers on various packaging and labeling equipment were not operational during undetermined periods. The inoperable bar code readers failed to detect incorrect labeling materials used in the packaging and labeling of batches of (several drug products). The failure to detect the incorrect labeling materials resulted in labeling mix-ups and subsequent release and distribution of mislabeled products. |
| Product: Software
for a point of care lab system Reason: Possible sample results mismatch with patient information. |
| Product: Laser
bar code scanners being sold in the USA (several enforcement occurrences) Reason: Product failed to comply with the Federal laser product performance standard. |
| Product: Laser
bar code scanners being imported into the USA (numerous
enforcement occurrences) Reason: Product failed to comply with the Federal laser product performance standard and was not permitted to enter into the USA |
| Product: Various in vitro diagnostic reagents Reason: Products are misbranded in that: 1. slides were incorrectly identified with the incorrect bar code; 2. cartridges in the lot were incorrectly identified with the incorrect bar code |
| Product: Drug
Tablets Reason: Product is misbranded in that the product bore a bar code for a different drug. |
| Product: Catheters Reason: Inability to scan the serial number bar code prevents the use of some units. |
| Product: Drug
Tablets Reason: Mis-labeling - Shipping carton bears incorrect NDC Bar Code. |
| Product: Diagnostic
Test Kits Reason: The barcode had an error that caused the system to reject it. The printing error prevents the barcode from being read and the instruments will not process the assay and patient results will not be obtained. |
| Product: Diagnostic
Reagents Reason: The calibration barcode packaged with the lot was erroneously coded. |
| Product: Clinical
Chemical Analyzer System Reason: The barcode reader can read the wrong sample barcode, mismatch the test results, and report them under the wrong sample. |
| Product:
In-vitro diagnostic test kits Reason: The kit expiration date on the human-readable label text differs from the expiration date embedded in the barcode on the kit label. |
| Product:
Drug Tablets Reason: Drug product labeling contained the bar code for a different drug product. |
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visit the FDA website for full details, (and search using the term 'bar code' or 'barcode'). |
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